BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDCOMM

    MDR report key: 2578637 · Received May 14, 2012

    Report

    Report Number
    1217157-2012-00016
    Event Type
    Other
    Date Received
    May 14, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 20, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, APC
    Product Code
    GKR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER FURTHER REPORTED THAT THE SAMPLE CAME OVER TO RAPIDCOMM AS A PROFICIENCY AND WAS FOUND IN THE PROFICIENCY REPORTS. CUSTOMER FURTHER STATES SHE WAS WORKING WITH PROFICIENCY PREVIOUSLY. THE NEXT SHIFT RAN THIS SAMPLE AND IT IS BELIEVED THE LAST PT WAS SELECTED WHICH POPULATED THE PROFICIENCY PREFIX "API" AND THE SAMPLE WAS SENT TO RAPIDCOMM AND ROUTED TO PROFICIENCY. CUSTOMER THEN REALIZED THAT PT IDENTIFICATION WAS INCORRECT AND MADE THE EDIT AT THE ANALYZER AND TRIED TO RESEND. THE SAMPLE DID NOT RESEND BECAUSE RAPIDCOMM IDENTIFIED THIS SAMPLE AS A DUPLICATE. THE SAMPLE WAS ENTERED MANUALLY IN THE LIS SYSTEM THE NEXT MORNING. TECHNICAL SUPPORT WAS CONTACTED BY THE CUSTOMER AND WAS ABLE TO RECLASSIFY THE SAMPLE FOR THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS SAMPLE RESULT DID NOT CORRECTLY TRANSFER INTO RAPIDCOMM LABORATORY INFORMATICS PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDCOMM RAPIDCOMM GKR SIEMENS HEALTHCARE DIAGNOSTICS, APC RAPIDCOMM

    Patients

    Seq Age Sex Outcome Treatment
    1